While most industry analysts had their hands full with recently released ASCO abstracts, a handful of clinical wins flew largely under the radar. The catastrophe that nearly cut Halozyme Therapeutics' (NASDAQ: HALO ) market cap in half might reverse somewhat. Loss mitigation aside, the biggest winners were in diabetes. It looks like Eli Lilly (NYSE: LLY ) might have a leg up in the growing market for long-lasting insulin. Outright innovation earned biggest win for Isis Pharmaceuticals (NASDAQ: ISIS ) and its novel approach to treating type 2 diabetes.
A second chance
First up is Halozyme, with more of a save than an actual win. This company found a safety net near the bottom of a freefall that began last month. It began April with a major catastrophe when a data monitoring committee (DMC) recommended stopping a pancreatic cancer trial with its candidate PEGPH20.
After some consideration from the DMC, the company's future is looking much brighter. When Halozyme reported earnings last Monday, it included a positive statement regarding the ill-fated trial. The DMC has considered Halozyme's amended protocol and now supports continued enrollment of patients. It's an important step, but the trial is still under a clinical hold placed by the FDA, so let's not get too confident yet.
Keep your eyes open for an announcement from the agency. The company's stock barely moved in response to the DMC reconsideration. If the FDA eventually lifts the hold, investors might regain some of what was lost following the initial halt.
Once-daily insulin contender
Runner-up for the biggest win of the week goes to Eli Lilly. Last Monday, the beleaguered drug major earned some bragging rights for its basal insulin treatment. In three head-to-head trials, peglispro was more efficacious than Sanofi's (NYSE: SNY ) Lantus at reducing blood glucose levels for type 2 diabetes patients. In addition to controlling blood glucose, weight gain reductions among peglispro patients was icing on the cake.
After a couple years years of sinking revenues, Eli Lilly badly needs a big win. Sanofi booked nearly $2 billion in first quarter Lantus sales and growth is strong. Taking a significant share of the long lasting insulin market could help Lilly return to growth. With these results in hand, peglispro may have a decent chance. There is one potential issue that may rain on the parade -- in the trial, an increase in liver enzymes (a potential -- emphasis on potential -- sign of liver toxicity) was noted in patients, so stay tuned for more data. Of course, Lilly needs to win an approval for the once-daily diabetes treatment first before we can really talk commercialization. Don't hold your breath, as the company doesn't plan to file with U.S. or EU regulators until early next year.
While Eli Lilly was making incremental advances with insulin, Isis Pharmaceuticals' unique angle of attack earned it the biggest clinical win of the week. Shares of the RNA antisense pioneer popped Wednesday morning after announcing positive results from a 75-patient mid-stage trial with ISIS-GCGR in type 2 diabetes patients.
The winning candidate is supposed to control blood sugar by limiting the effects of glucagon, a hormone that opposes the action of insulin. Uncontrolled secretion of glucagon becomes increasingly common in type 2 diabetes patients as their disease progresses.
Curtailing the expression of glucagon receptors should be an effective method for controlling blood sugar in advanced patients, but as a first-in-class therapy there are plenty of unknowns. If there is one symptom that could bring the program crashing down, it's signs of liver damage. Patients receiving ISIS-GCGR showed liver enzyme elevations consistent with the pharmacology of glucagon receptor inhibition. The elevations were not associated with typical indicators of liver damage, but regulators are typically hypersensitive about safety issues with new diabetes therapies. Isis intends to break out more details at the annual meeting of the American Diabetes Association in mid-June. Investors will want to watch out for further signs of safety issues during the presentation.
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